Hypothermic Perfusion During Hemihepatectomy
Currently, hepatic resection is often the only curative treatment for primary or secondary hepatic malignancies and is also frequently performed in patients with benign liver tumors to prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays associated with low mortality and acceptable morbidity. As result of that, an increasing number of patients is currently under consideration for resection of more complex or large tumors, thus requiring extensive resection procedures. Application of vascular exclusion (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood loss, which is one of the most important factors affecting peri-operative outcomes. However, vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect, which adversely impacts postoperative liver function and regeneration. Additional cooling of the liver by means of hypothermic perfusion is expected to further reduce intraoperative blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this pilot study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy under vascular exclusion. Consequently, an overall improvement in postoperative outcomes is expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a better ability of the liver remnant to regenerate.
To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with retrograde outflow (R-IHP) of the FRL.
The study is designed as a prospective randomized pilot study in 18 patients (9 interventions and 9 controls) to assess the effects of the proposed intervention. Additionally, 4 patients will be included separately for assessment of the intervention's feasibility prior to randomized inclusion.
Eligible patients for participation in this study are those planned to undergo right hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver tumor, and who do not suffer from any hepatic co-morbidity that might influence postoperative outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C infection).
During right hemihepatectomy, the FRL of patients allocated to the intervention group will be perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||In Situ Hypothermic Perfusion During Right Hemihepatectomy|
- Postoperative hepatocellular damage [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]Hepatocellular damage expressed as an postoperative increase in transaminases (i.e., AST and ALT).
- Intraoperative blood loss [ Time Frame: 2-3 hours ] [ Designated as safety issue: No ]Blood loss during surgery
- Postoperative complications [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]Incidence of surgery-related complications
- Regeneration of liver function and volume [ Time Frame: 3 days ] [ Designated as safety issue: No ]Regeneration of liver function (measured via hepatobiliary scintigraphy) and -volume (measured via CT volumetry).
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Vascular inflow occlusion
Patients that will receive intermittent vascular inflow occlusion, the standard method for vascular occlusion at our institution, during liver resection.
Experimental: Hypothermic perfusion
Patients will receive in situ hypothermic perfusion of the future remnant liver during liver resection.
Procedure: In situ hypothermic perfusion
In situ perfusion of the future remnant liver with chilled lactated Ringer's solution during liver resection.
Other Name: In situ hypothermic preservation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499979
|Contact: Megan J. Reiniers, MScfirstname.lastname@example.org|
|Contact: Prof. Thomas M. van Gulik, MD, PhDemail@example.com|
|Academic Medical Center (AMC)||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Contact: Megan J. Reiniers, MSc +31205666683 firstname.lastname@example.org|
|Study Chair:||Prof. Thomas M. van Gulik, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Megan J. Reiniers, MSc||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Rowan F. van Golen, MSc||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|